A Study to Evaluate Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure

Rhinitis, Allergic Clinical Trial

Official title:

A Double-Blind Placebo-Controlled Crossover Study to Evaluate Objective Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure in an Environmental Exposure Unit

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03443843
• Other study ID #: 19880
• Status: Completed
• Phase: Phase 4
• Start date: February 21, 2018
• Est. completion date: May 11, 2018

Study information

• Verified date: December 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate changes in nasal airflow caused by loratadine 5 mg/pseudoephedrine sulfate 120 mg (Claritin D) tablet and fluticasone propionate 50 mcg per spray nasal spray (Flonase) in subjects suffering from nasal congestion and other allergy symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 11, 2018
• Est. primary completion date: May 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Healthy, ambulatory male and female subjects between 18 to 65 years of age

• Self-reported seasonal allergic rhinitis to ragweed pollen for at least 2 years prior to screening

• Documented positive skin prick test response to common ragweed (ambrosia artemisiifolia) pollen at screening or within the previous 12 months conducted at research site (prick with wheal diameter >= 5 mm larger than the diluent response)

• In order to qualify to continue to treatment phase, at the end of priming phase (which is 3 hours), Total Symptom Score (TSS) has to be = 7, with nasal congestion score alone = 2 and change in peak nasal inspiratory flow (PNIF) has to be = 15% from pre-prime baseline;

• Subject is willing to stop use of current decongestant and allergy medications at the start of the washout period prior to priming and during the trial

• At the discretion of the investigators, subjects may be considered with self-reported mild intermittent asthma (Using <=2 doses of SABA (short-acting beta agonists) per week) or exercise-induced asthma

• Subject is free of any clinically significant disease that required a physician´s care and/or would interfere with trial evaluations, procedures or participation

• Subject is able to repeatedly and reliably perform PNIF measurements and must achieve PNIF value of >=60L/min at screening

• Subject must be capable of reading English and willing to participate in all aspects of the study

Exclusion Criteria:

• Any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of loratadine, pseudoephedrine and fluticasone propionate, or might interfere with the trial. These may include subjects with injury or surgery to the nose that is not fully healed, fungal infections, immunocompromised conditions (HIV, tuberculosis), severe nosebleeds, narrow-angle glaucoma, chickenpox measles..., severe facial pain or thick nasal discharge, sinusitis, constant whistling sound from the nose, structured abnormality of the nose, uncontrolled thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease ischemic heart disease, uncontrolled high blood pressure, symptomatic prostatic hypertrophy, bladder neck obstruction, hepatic insufficiency, renal disease

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D)
Single dose of Loratadine/pseudoephedrine in tablet 5 mg/120 mg orally
• Placebo tablet
Placebo tablet orally
• Fluticasone Propionate
Fluticasone Propionate Nasal Spray 50mcg per spray, 2 sprays per nostril
• Placebo spray
Placebo Nasal Spray, 2 sprays per nostril

Locations

Country	Name	City	State
Canada	Kingston General Hospital	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average percent change in PNIF (Peak Nasal Inspiratory Flow) from 0 to 4 hours after dosing		Up to 4 hours

External Links

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